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Biomarkers for the Early Identification of Sepsis in the Emergency Department

Early Biomarkers of Sepsis Identification in the Emergency Department

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02707718
Acronym
BIPS
Enrollment
320
Registered
2016-03-14
Start date
2016-03-01
Completion date
2018-03-03
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, biomarker, prognostic, emergency department, diagnosis

Brief summary

Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

Detailed description

The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis. Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection. Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.

Interventions

BIOLOGICALblood sampling

during the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement

Sponsors

Institut Pasteur
CollaboratorINDUSTRY
Bio-Rad Laboratories
CollaboratorINDUSTRY
Pitié-Salpêtrière Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam

Exclusion criteria

* patient minor under 18-year * pregnancy * anticipated no follow-up possible (homeless...) * Refusal to participate * patient under curators, prisoner

Design outcomes

Primary

MeasureTime frameDescription
sepsis diagnosis30-day after inclusionAmong the patients included in the study with a sepsis suspicion, the primary outcome measure will be a final diagnosis of sepsis adjudicated on the medical file and 30-day follow-up, by an expert panel blind for the biomarkers studied

Secondary

MeasureTime frameDescription
severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up30-day after inclusionAmong the patients included in the study with a sepsis suspicion, a diagnosis of severe sepsis and/or septic shock will be adjudicated on the medical file and 30-day follow-up by an expert panel blind for the biomarkers studied. ICu admission and death will be recorded by the medical file and 30-day phone interview.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026